Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091073
Company: ACTAVIS LABS UT INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TESTOSTERONE TESTOSTERONE 50MG/5GM PACKET GEL;TRANSDERMAL Prescription AB2 No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/18/2017 ORIG-1 Approval Not Applicable Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/091073Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/21/2019 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

TESTOSTERONE

GEL;TRANSDERMAL; 50MG/5GM PACKET
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TESTIM TESTOSTERONE 50MG/5GM PACKET GEL;TRANSDERMAL Prescription Yes AB2 021454 AUXILIUM PHARMS LLC
TESTOSTERONE TESTOSTERONE 50MG/5GM PACKET GEL;TRANSDERMAL Prescription No AB2 091073 ACTAVIS LABS UT INC
VOGELXO TESTOSTERONE 50MG/5GM PACKET GEL;TRANSDERMAL Prescription No AB2 204399 UPSHER SMITH LABS

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